Ultrasound device for probe guidance and sterilizable shield for same

• US 9,351,704 B2
• Filed: 04/07/2015
• Issued: 05/31/2016
• Est. Priority Date: 10/09/2009
• Status: Active Grant

• Current Assignee: Soma Research, LLC
• Original Assignee: M. Dexter Hagy
• Inventors: Ridley, Stephen F., Hagy, M. Dexter
• Primary Examiner(s): Lamprecht, Joel
• Application Number:
  US14/680,424
• Publication Number:
  US 20150209008A1
• Time in Patent Office: 420 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 1/00142 with means for preventing contamination, e.g. by using a sanitary sheath
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 2017/00296 mounted on an endoscope
• CPC Class Codes: A61B 2017/00858 high friction or non-slip
• CPC Class Codes: A61B 2017/3405 using mechanical guide means
• CPC Class Codes: A61B 2017/3413 guided by ultrasound
• CPC Class Codes: A61B 46/10 specially adapted for instruments, e.g. microscopes
• CPC Class Codes: A61B 8/0833 involving detecting or locating foreign bodies or organic structures
• CPC Class Codes: A61B 8/0841 for locating instruments
• CPC Class Codes: A61B 8/4209 by using holders, e.g. positioning frames
• CPC Class Codes: A61B 8/4254 using sensors mounted on the probe
• CPC Class Codes: A61B 8/4281 characterised by sound-transmitting media or devices for coupling the transducer to the tissue
• CPC Class Codes: A61B 8/4422 related to hygiene or sterilisation
• CPC Class Codes: A61B 8/461 Displaying means of special interest

Abstract

Disclosed are medical probe devices and methods for use guiding of percutaneous probes during medical procedures. The probe devices include an ultrasound transducer housing having a passage therethrough configured to accommodate a probe. The devices can be utilized to guide a probe through the probe guide to a percutaneous target with real time visualization of the probe during the procedure. In addition, the devices can include a sterilizable shield including a sterile probe guide such that the transducer housing itself can be separated from a subject by a sterile barrier. The sterilizable shield can be a single-use shield that can prevent contamination and re-use of the shield. The devices can define a beneficial geometry conducive to use by a single operator that can be utilized for percutaneous targets near the skin surface and can enable excellent contact between the device and the skin surface of a subject.

Claims

1. A single-use sterilizable shield comprising a first section, a second section and a fastener for connecting the first section and the second section to one another, the fastener comprising a tab configured to be permanently broken upon disconnection and separation of the first section and the second section from one another, the single-use sterilizable shield comprising a probe guide, the single-use sterilizable shield comprising a skin contacting surface that defines an opening therethrough, the opening being a terminus of the probe guide, the skin contacting surface comprising a first portion defining a first plane and a second portion defining a second plane, the first portion and the second portion being contiguous, the first portion and the second portion both being configured to contact the skin of a subject during an ultrasound procedure on the subject, the first plane and the second plane intersecting one another to define an angle therebetween that is greater than about 150°

and less than 180°

, the angle being determined between the first and second portions of the skin contacting surface and external to the shield.

2. The single-use sterilizable shield of claim 1, wherein the probe guide is adapted for receipt in a probe guide opening defined by an ultrasound transducer housing.

3. The single-use sterilizable shield of claim 1, the first portion of the skin contacting surface defining the opening therethrough.

4. The single-use sterilizable shield of claim 3, the second portion of the skin contacting surface being adapted to conform to the base of an ultrasound transducer housing such that an ultrasonic beam transmitted from an ultrasound transducer held within the ultrasound transducer housing issues from the second portion.

5. The single-use sterilizable shield of claim 1, the second section comprising the skin contacting surface.

6. The single-use sterilizable shield of claim 5, the first section comprising a first portion of the probe guide and the second section comprising a second section of the probe guide.

7. The single-use sterilizable shield of claim 1, the sterilizable shield further comprising a third section, the third section comprising the probe guide, the third section being removably attachable to the first section or the second section.

8. The single-use sterilizable shield of claim 1, the sterilizable shield further comprising at least one raised ridge on said skin contacting surface.

9. The single-use sterilizable shield of claim 1, the sterilizable shield further comprising a clamp for clamping a probe in the probe guide.

10. A method for guiding a probe to a percutaneous target comprising:

seating an ultrasound transducer housing within a first section of a sterilizable shield, the ultrasound transducer housing including an ultrasound transducer for transmitting an ultrasonic beam and receiving reflections of the ultrasonic beam;

aligning a second section of the sterilizable shield with the first section of the sterilizable shield, wherein the second section of the sterilizable shield encloses a portion of the ultrasound transducer housing, the sterilizable shield comprising a skin contacting surface, the skin contacting surface comprising a first portion defining a first plane and a second portion defining a second plane, the first portion and the second portion being contiguous, the first plane and the second plane intersecting one another to define an angle therebetween that is greater than about 150° and

less than 108°

, the angle being determined between the first and second portions of the skin contacting surface and external to the shield;

fastening the first and second sections of the sterilizable shield to one another by use of a single-use fastener to enclose at least that portion of the ultrasound transducer housing that includes the ultrasound transducer within the sterilizable shield;

locating the first portion and the second portion of the skin contacting surface adjacent to the skin of a subject;

guiding a probe defining a probe tip such that the probe tip arrives at the percutaneous target; and

disassembling the first section and the second section from one another, wherein the single-use fastener comprises a tab that is permanently broken upon the disassembly.

11. The method according to claim 10, wherein the sterilizabie shield comprises a probe guide.

12. The method according to claim 11, wherein the ultrasound transducer housing defines a probe guide opening, the probe guide being received into the probe guide opening upon seating the ultrasound transducer housing within the first section of the sterilizable shield.

13. The method according to claim 11, the first section of the sterilizable shield comprising a first section of the probe guide and the second section of the sterilizable shield comprising a second section of the probe guide, the first and second sections of the probe guide being attached to one another upon fastening of the first and second sections of the sterilizable shield to one another.

14. The method according to claim 10, the method further comprising attaching a probe guide portion to the steritizable shield, the probe guide portion comprising a probe guide.

15. The method according to claim 10, further comprising clamping the probe in the probe guide when the probe tip is at the percutaneous target.

16. The method according to claim 10, further comprising transmitting an ultrasonic beam from the transducer assembly and through the skin contacting surface, and forming a sonogram of the percutaneous target in response to the reflections of the ultrasonic beam.

17. The method according to claim 16, further comprising forming a virtual image of the probe on the sonogram.